Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Assessment of the global Performance of the VistaCare® device in standard medical practice
研究概览
简要总结
Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.
详细描述
The study is an open-label, prospective, multicenter, post-CE mark (European Conformity assessment indicating marketing approval in Europe) study to assess the safety and performance of the VistaCare® device in the treatment of wounds. The duration of patient follow-up is up to 30 days, with intermediate visits at 3, 7, 15 and 30 days following initiation of treatment with the device.
Up to 30 patients will be recruited in the trial. Assessments will include clinical status, wound status, standardized photography, TcPO2 (trans-cutaneous oxygen pressure assessment) in a study sub-population, visual analogy scales to assess pain and comfort and adverse events monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female consenting and able patients aged 18 or more affiliated to social security
- •presenting with acute or chronic traumatic or surgical lower limb wounds (excluding tumoral excision)
- •presenting with no intercurrent pathology which in the opinion of the investigator may interfere with the capacity for wound healing
- •patients whose wound is compatible in terms of location with VistaCare treatment
- •patient whose wound has a minimal surface of 10 cm2
- •patient whose wound does not need surgical Peterson after inclusion (if needed should be performed prior to inclusion)
排除标准
- •Female patients pregnant, lactating, or of childbearing age and not using adequate contraception (pregnancy test mandatory)
- •patients incapable of making an informed decision about participation
- •patients presenting a condition that interferes with adequate wound healing capacity (uncontrolled diabetes, heavy smokers, auto-immune disease)
- •concurrent treatment or treatment within one month prior to inclusion with local or systemic corticosteroids, immunosuppresseurs, chemotherapy or radiotherapy
- •wound location incompatible with VistaCare
- •general infection signs at the time of inclusion (fever, lymphangitis, pus ...)
- •patients presenting with important uncontrolled hemorrhage at the time of inclusion
- •patients previously recruited into this trial or any other trial within 1 month, or currently in the exclusion timeframe of another trial
- •patients with a wound surface less than 10 cm2
- •patient with a would previously treated with hyperbaric chamber
- •legally incapacitated, under guardianship or psychiatric patients
- •emergency condition prohibiting adequate patient consent prior to inclusion
结局指标
主要结局
Assessment of the global Performance of the VistaCare® device in standard medical practice
时间窗: up to 30 days
Assessment of the global performance of the VistaCare® medical device as compared to its labeled performance in the approved indication (wound healing). This will be assessed through a global clinical assessment by the investigator of the wound improvement condition throughout the study visits, measured in 3 grades ranging from Aggravation (worst assessment), through Static (no improvement) to Improved (best assessment), taking into consideration the wound healing stage and general clinical condition per investigator's assessment.
Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice
时间窗: up to 30 days
Assessment of the global safety of VistaCare® in current medical practice in patients with acute or chronic lower limb wounds through monitoring of concurrent averse events throughout the study duration. This will be assessed through the frequency of occurrence of device-related events, throughout the patient's participation in the trial
次要结局
- Assessment of time under VistaCare treatment till secondary treatment decision(up to 15 days)
- Safety assessment of the VistaCare® treatment through monitoring of the frequency of adverse events(throughout 30 days)
- Quality of Life assessments(throughout 30 days)
- Duration of hospitalization(throughout 30 days)
- Wound surface calorimetric assessment of wound status(30 days)
- TcPO2 assessment(up to 30 days)